Overview
Reference Number: JO-1911-440760
Senior Regulatory Affairs Associate
Rate: Negotiable
Job Type: Contract
Location: Central London / West End
Senior Regulatory Affairs Associate
12 Month Contract
Cambridge or Middlesex based
Hourly Rate DOE
This internationally recognised biopharmaceutical firm are actively looking for a Senior Regulatory Affairs Associate to join their established team either based from their Cambridge or London site. Working within General Medicines working on national VHP submissions across the EU. If you have 1-3 years Regulatory experience preferably working on VHP and Clinical Trial Applications, this position could be the role for you.
Job Responsibilities include;
– Assist in the creation and submission of regulatory documents
– Assist Regional Regulatory Lead to support regulatory pre filing activities (CTA/IMPD development and submission and support pre-MAA filings)
– Provide and maintain CTA/MA documentation support (variations substantial amendments)
– Lifecyle management including label variation and safety updates
– Ensure compliance via timely submissions to regulatory agencies
Candidate Requirements include;
– Life Sciences degree or similar
– 1-3 years Regulatory experience predominately within a pharmaceutical environment
– Familiarity with ETMS/ Veeva would be advantageous
– Previous experience working on VHP submissions
– Prior experience working across the EU market
– Must be eligible to live and work in the United Kingdom
If this position is of interest to yourself please call Sophie at Regulatory Professionals on 0118 952 2797 or alternatively forward your CV to sophie@regulatoryprofessionals.com.
